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  5. Public Meeting for Levothyroxine Sodium Therapeutic Equivalence May 23, 2005, Washington, DC Presentations
  1. Postmarket Drug Safety Information for Patients and Providers

Public Meeting for Levothyroxine Sodium Therapeutic Equivalence May 23, 2005, Washington, DC Presentations

 

  • Overview of FDA General Regulatory Requirements and Methods for Demonstration of Therapeutic Equivalence, Dale P. Conner, Pharm.D., FDA

  • Report of Recently Approved Products’ Performance in Bioequivalence Testing, Barbara M. Davit, Ph.D, FDA

  • Levothyroxine Sodium Tables: An FDA Overview from the CMC Standpoint, Eric P. Duffy, PhD, FDA

  • Limitations of Current Bioequivalence Standards, James V. Hennessey M.D., Brown Medical School

  • Levothyroxine Sodium: A Widely Employed Narrow Therapeutic Range Drug,  Paul W. Ladenson, M.D.  Johns Hopkins Univrsity School of Medicine

  • Results of Two T4 Bioavailability Studies, Michael J. Lamson, Ph.D. King Pharmaceuticals

  • Levothyroxine Therapeutic Equivalence Workshop: Presentation Before the Food and Drug Administration, John Leonard, MD, Abbott

  • Use of TSH for Bioequivalence, Robert Lionberger, Ph.D., FDA

  • Bioavailability/Bioequivalence Studies in Evaluation of New Levothyroxine Products (PDF - 226KB), Hank Malinowski, Ph.D., FDA

  • FDA Summary, David G. Orloff, M.D., FDA

  • TSH as a Pharmacodynamic Marker Why do We Need It?, E. Chester Ridgway, M.D., University of Colorado Health Sciences Center

  • FDA Levothyroxine Workshop, Representatives from Sandoz

  • Levothyroxine and/or TSH for Determination of Bioequivalence: Study Design Considerations, Steven I. Sherman, M.D., University of Texas M.D. Anderson Cancer Center

  • Presentation for Joint Public Meeting on Equivalence of Levothyroxine Sodium Products, Frank Sisto, Mylan Pharmaceuticals

  • Concerns regarding Dispensing Practices and Bioequivalence of Levothyroxine, Leonard Wartofsky, M.D., Washington Hospital Center

 

 
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